« iepriekšējāTurpināt »
sample of whole blood. This device is intended for adjunctive use in monitoring or predicting cancer disease progression, response to therapy, and for the detection of recurrent disease.
(b) Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled "Class II Special Controls Guidance Document: Immunomagnetic Circulating Cancer Cell Selection and Enumeration System.” See 8866.1(e) for availability of this guidance document. (69 FR 26038, May 11, 2004)
$ 866.6030 AFP-L3% immunological test
system. (a) Identification. An AFP-L3% immunological test system is an in vitro device that consists of reagents and an automated instrument used to quantitatively measure, by immunochemical techniques, AFP and AFP-L3 subfraction in human serum. The device is intended for in vitro diagnostic use as an aid in the risk assessment of patients with chronic liver disease for development of hepatocellular carcinoma, in conjunction with other laboratory findings, imaging studies, and clinical assessment.
(b) Classification. Class II (special controls). The special control is FDA'S guidance document entitled “Class II Special Controls Guidance Document: AFP-L3% Immunological Test Systems." See $ 866.1(e) for the availability of this guidance document. [70 FR 57749, Oct. 4, 2005]
868.1120 Indwelling blood oxyhemoglobin
concentration analyzer. 868.1150 Indwelling blood carbon dioxide
partial pressure (Pcoz) analyzer. 868.1170 Indwelling blood hydrogen ion con
centration (pH) analyzer. 868.1200 Indwelling blood oxygen partial
pressure (Po2) analyzer. 868.1400 Carbon dioxide gas analyzer. 868.1430 Carbon monoxide gas analyzer. 868.1500 Enflurane gas analyzer. 868.1575 Gas collection vessel. 868.1620 Halothane gas analyzer. 868.1640 Helium gas analyzer. 868.1670 Neon gas analyzer. 868.1690 Nitrogen gas analyzer. 868.1700 Nitrous oxide gas analyzer. 868.1720 Oxygen gas analyzer. 868.1730 Oxygen uptake computer. 868.1750 Pressure plethysmograph. 868.1760 Volume plethysmograph. 868.1780 Inspiratory airway pressure meter. 868.1800 Rhinoanemometer. 868.1840 Diagnostic spirometer. 868.1850 Monitoring spirometer. 868.1860 Peak-flow meter for spirometry. 868.1870 Gas volume calibrator 868.1880 Pulmonary-function data calcu
lator. 868.1890 Predictive pulmonary-function
value calculator. 868.1900 Diagnostic pulmonary-function in
terpretation calculator. 868.1910 Esophageal stethoscope. 868.1920 Esophageal stethoscope with elec
trical conductors. 868.1930 Stethoscope head. 868.1965 Switching valve (ploss). 868.1975 Water vapor analyzer.
Subpart C-Monitoring Devices
Subpart A-General Provisions Sec. 868.1 Scope. 868.3 Effective dates of requirement for pre
market approval. 868.9 Limitations of exemptions from sec
tion 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
868.2025 Ultrasonic air embolism monitor. 868.2300 Bourdon gauge flowmeter. 868.2320 Uncompensated thorpe tube flow
meter. 868.2340 Compensated thorpe tube flow
meter. 868.2350 Gas calibration flowmeter. 868.2375 Breathing frequency monitor. 868.2377 Apnea monitor. 868.2380 Nitric oxide analyzer. 868.2385 Nitrogen dioxide analyzer. 868.2450 Lung water monitor. 868.2480 Cutaneous carbon dioxide (PcCO2)
monitor. 868.2500 Cutaneous oxygen (Pc02) monitor. 868.2550 Pneumotachometer. 868.2600 Airway pressure monitor. 868.2610 Gas pressure gauge. 868.2620 Gas pressure calibrator. 868.2700 Pressure regulator. 868.2775 Electrical peripheral nerve stimu
lator. 868.2875 Differential pressure transducer. 868.2885 Gas flow transducer. 868.2900 Gas pressure transducer.
Subpart B-Diagnostic Devices
868.1030 Manual algesimeter. 868.1040 Powered algesimeter. 868.1075 Argon gas analyzer. 868.1100 Arterial blood sampling kit.
Subparts D-E [Reserved] Subpart F-Therapeutic Devices
868.5740 Tracheal/bronchial differential Fals
tilation tube. 868.5750 Inflatable tracheal tube cuff. 868.5760 Cuff spreader. 868.5770 Tracheal tube fixation device. 868.5780 Tube introduction forceps. 868.5790 Tracheal tube stylet. 868.5795 Tracheal tube cleaning brush. 868.5800 Tracheostomy tube and tube cufi. 868.5810 Airway connector. 868.5820 Dental protector. 868.5830 Autotransfusion apparatus. 868.5860 Pressure tubing and accessories. 868.5870 Nonrebreathing valve. 868.5880 Anesthetic vaporizer. 868.5895 Continuous ventilator. 868.5905 Noncontinuous ventilator (IPPBI. 868.5915 Manual emergency ventilator. 868.5925 Powered emergency ventilator. 868.5935 External negative pressure vent:
lator. 868.5955 Intermittent mandatory ventils
tion attachment. 868.5965 Positive end expiratory pressur
breathing attachment. 868.5975 Ventilator tubing. 868.5995 Tee drain (water trap).
868.5090 Emergency airway needle. 868.5100 Nasopharyngeal airway. 868.5110 Oropharyngeal airway. 868.5115 Device to relieve acute upper air
way obstruction. 868.5120 Anesthesia conduction catheter. 868.5130 Anesthesia conduction filter. 868.5140 Anesthesia conduction kit. 868.5150 Anesthesia conduction needle. 868.5160 Gas machine for anesthesia or anal
gesia. 868.5165 Nitric oxide administration appa
ratus. 868.5170 Laryngotracheal topical anesthesia
applicator. 868.5180 Rocking bed. 868.5220 Blow bottle. 868.5240 Anesthesia breathing circuit. 868.5250 Breathing circuit circulator. 868.5260 Breathing circuit bacterial filter. 868.5270 Breathing system heater. 868.5280 Breathing tube support. 868.5300 Carbon dioxide absorbent. 868.5310 Carbon dioxide absorber. 868.5320 Reservoir bag. 868.5330 Breathing gas mixer. 868.5340 Nasal oxygen cannula. 868.5350 Nasal oxygen catheter. 868.5365 Posture chair for cardiac or pul
monary treatment. 868.5375 Heat and moisture condenser (arti
ficial nose). 868.5400 Electroanesthesia apparatus. 868.5420 Ether hook. 868.5430 Gas-scavenging apparatus. 868.5440 Portable oxygen generator. 868.5450 Respiratory gas humidifier. 868.5460 Therapeutic humidifier for home
use. 868.5470 Hyperbaric chamber. 868.5530 Flexible laryngoscope. 868.5540 Rigid laryngoscope. 868.5550 Anesthetic gas mask. 868.5560 Gas mask head strap. 868.5570 Nonrebreathing mask. 868.5580 Oxygen mask. 868.5590 Scavenging mask. 868.5600 Venturi mask. 868.5610 Membrane lung for long-term pul
monary support. 868.5620 Breathing mouthpiece. 868.5630 Nebulizer. 868.5640 Medicinal nonventilatory nebulizer
(atomizer). 868.5650 Esophageal obturator. 868.5655 Portable liquid oxygen unit. 868.5665 Powered percussor. 868.5675 Rebreathing device. 868.5690 Incentive spirometer. 868.5700 Nonpowered oxygen tent. 868.5710 Electrically powered oxygen tent. 868.5720 Bronchial tube. 868.5730 Tracheal tube.
868.6100 Anesthetic cabinet, table, or tray. 868.6175 Cardiopulmonary emergency cart 868.6225 Nose clip. 868.6250 Portable air compressor. 868.6400 Calibration gas. 868.6700 Anesthesia stool. 868.6810 Tracheobronchial suction catheter 868.6820 Patient position support. 868.6885 Medical gas yoke assembly.
AUTHORITY: 21 U.S.C. 351, 360, 3600, 36le. 360j, 371.
SOURCE: 47 FR 31142, July 16, 1982, unless otherwise noted.
Subpart A-General Provisions $868.1 Scope.
(a) This part sets forth the classifica. tion of anesthesiology devices intended for human use that are in commercia distribution.
(b) The identification of a device in a regulation in this part is not a precise description of every device that is, of will be, subject to the regulation. A manufacturer who submits a premarket notification submission for å device under part 807 may not show merely that the device is accurately described by the section title and identification provisions of a regulation in
tis part, but shall state why the de- mercially distributed without FDA's ce is substantially equivalent to issuance of an order approving a PMA her devices, as required by $ 807.87. or declaring completed a PDP for the (c) To avoid duplicative listings, an device. If FDA promulgates a regulaiesthesiology device that has two or tion under section 515(b) of the act reore types of uses (e.g., used both as a quiring premarket approval for a deagnostic device and as a therapeutic vice, section 501(f)(1)(A) of the act apvice) is listed only in one subpart. plies to the device. (d) References in this part to regu
(b) Any new, not substantially equivtory sections of the Code of Federal
alent, device introduced into commeregulations are to chapter I of title 21,
cial distribution on or after May 28, nless otherwise noted.
1976, including a device formerly mar(e) Guidance documents referenced in
keted that has been substantially aliis part are available on the Internet
tered, is classified by statute (section http://www.fda.gov/cdrh/guid
513(f) of the act) into class III without zce.html
any grace period and FDA must have 2 FR 17734, May 11, 1987, as amended at 67 issued an order approving a PMA or deR 76681, Dec. 13, 2002)
claring completed a PDP for the device
before the device is commercially dis868.3 Effective dates of requirement
tributed unless it is reclassified. If for premarket approval.
FDA knows that a device being comA device included in this part that is mercially distributed may be a "new" lassified into class III (premarket ap
device as defined in this section beroval) shall not be commercially dis
cause of any new intended use or other ributed after the date shown in the
reasons, FDA may codify the statutory egulation classifying the device unless
classification of the device into class he manufacturer has an approval
III for such new use. Accordingly, the inder section 515 of the act (unless an
regulation for such a class III device xemption has been granted under sec
states that as of the enactment date of ion 520(g)(2) of the act). An approval
the amendments, May 28, 1976, the deinder section 515 of the act consists of
vice must have an approval under sec"DA's issuance of an order approving
tion 515 of the act before commercial in application for premarket approval
distribution. PMA) for the device or declaring comleted a product development protocol (52 FR 17734, May 11, 1987) PDP) for the device.
(a) Before FDA requires that a device $868.9 Limitations of exemptions from Commercially distributed before the
section 510(k) of the Federal Food, nactment date of the amendments, or
Drug, and Cosmetic Act (the act). 1 device that has been found substan The exemption from the requirement tially equivalent to such a device, has of premarket notification (section an approval under section 515 of the act 510(k) of the act) for a generic type of FDA must promulgate a regulation class I or II device is only to the extent under section 515(b) of the act requir- that the device has existing or reasoning such approval, except as provided ably foreseeable characteristics of in paragraph (b) of this section. Such a commercially distributed devices withregulation under section 515(b) of the in that generic type or, in the case of act shall not be effective during the in vitro diagnostic devices, only to the grace period ending on the 90th day extent that misdiagnosis as a result of after its promulgation or on the last using the device would not be associday of the 30th full calendar month ated with high morbidity or mortality. after the regulation that classifies the Accordingly, manufacturers of any device into class III is effective, which commercially distributed class I or II ever is later. See section 501(f)(2)(B) of device for which FDA has granted an the act. Accordingly, unless an effec- exemption from the requirement of tive date of the requirement for pre premarket notification must still submarket approval is shown in the regu- mit a premarket notification to FDA lation for a device classified into class before introducing or delivering for inMI in this part, the device may be com- troduction into interstate commerce
Subpart B-Diagnostic Devices
$868.1030 Manual algesimeter.
(a) Identification. A manual algesimeter is a mechanical device intended to determine a patient's sensitivity to pain after administration of an anesthetic agent, e.g., by pricking with a sharp point.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 8868.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of $ 820.180, with respect to general requirements concerning records, and $820.198, with respect to complaint files. (54 FR 25048, June 12, 1989, as amended at 66 FR 38793, July 25, 2001)
for commercial distribution the device when:
(a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only;
(b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or
(c) The device is an in vitro device that is intended:
(1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices;
(2) For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism;
(3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy;
(4) For assessing the risk of cardiovascular diseases; · (5) For use in diabetes management;
(6) For identifying or inferring the identity of a microorganism directly from clinical material;
(7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) or IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma;
(8) For noninvasive testing as defined in 8812.3(k) of this chapter; and
(9) For near patient testing (point of care). [65 FR 2313, Jan. 14, 2000]
$868.1040 Powered algesimeter.
(a) Identification. A powered algesimeter is a device using electrical stimulation intended to determine a patient's sensitivity to pain after administration of an anesthetic agent.
(b) Classification. Class II (performance standards).
$ 868.1075 Argon gas analyzer.
(a) Identification. An argon gas analyzer is a device intended to measure the concentration of argon in a gas mixture to aid in determining the patient's ventilatory status. The device may use techniques such as mass spectrometry or thermal conductivity.
(b) Classification. Class II (performance standards). 8868.1100 Arterial blood sampling kit.
(a) Identification. An arterial blood sampling kit is a device, in kit form. used to obtain arterial blood samples from a patient for blood gas determinations. The kit may include a syringe, needle, cork, and heparin.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in
subpart E of part 807 of this chapter Blood Gas Analyzers; Final Guidance subject to the limitations in 8 868.9. for Industry and FDA.' [47 FR 31142, July 16, 1982, as amended at 61 [47 FR 31142, July 16, 1982; 47 FR 40410, Sept. FR 1119, Jan. 16, 1996; 66 FR 38793, July 25, 14, 1982, as amended at 52 FR 17735, May 11, 2001]
1987; 66 FR 57368, Nov. 15, 2001) $868.1120 Indwelling
$ 868.1170 Indwelling blood hydrogen oxyhemoglobin concentration ana
ion concentration (pH) analyzer. lyzer.
(a) Identification. An indwelling blood (a) Identification. An indwelling blood hydrogen ion concentration (pH) anaoxyhemoglobin concentration analyzer
lyzer is a device that consists of a cathis a photoelectric device used to meas
eter-tip pH electrode and that is used ure, in vivo, the oxygen-carrying ca
to measure, in vivo, the hydrogen ion pacity of hemoglobin in blood to aid in
concentration (pH) in blood to aid in determining the patient's physiological
determining the patient's acid-base status.
balance. (b) Classification. Class III (premarket
(b) Classification. Class II (special
controls). The special control for this approval).
device is FDA's “Class II Special Con(c) Date PMA or notice of completion
trols Guidance Document: Indwelling of PDP is required. A PMA or notice of
Blood Gas Analyzers; Final Guidance completion of a PDP is required to be
for Industry and FDA.” filed with the Food and Drug Administration on or before September 21, 2004, [47 FR 31142, July 16, 1982, as amended at 52 for any indwelling blood
FR 17735, May 11, 1987; 66 FR 57368, Nov. 15, oxyhemoglobin concentration analyzer
2001) that was in commercial distribution 8868.1200 Indwelling blood oxygen before May 28, 1976, or that has, on or
partial pressure (Po2) analyzer. before September 21, 2004, been found
(a) Identification. An indwelling blood to be substantially equivalent to an in
oxygen partial pressure (Poz) analyzer dwelling blood oxyhemoglobin con
is a device that consists of a cathetercentration analyzer that was in com
tip Poz transducer (e.g., Po2 electrode) mercial distribution before May 28, 1976. Any
and that is used to measure, in vivo, other indwelling blood
the partial pressure of oxygen in blood oxyhemoglobin concentration analyzer
to aid in determining the patient's cirshall have an approved PMA or de
culatory, ventilatory, and metabolic clared completed PDP in effect before
status. being placed in commercial distribu
(b) Classification. Class II (special tion.
controls). The special control for this (47 FR 31142, July 16, 1982, as amended at 52 device is FDA's "Class II Special ConFR 17735, May 11, 1987; 52 FR 22577, June 12, trols Guidance Document: Indwelling 1987; 69 FR 34920, June 23, 2004)
Blood Gas Analyzers; Final Guidance
for Industry and FDA.” 8868.1150 Indwelling blood carbon dioxide partial pressure (Pco2) ana
[47 FR 31142, July 16, 1982; 47 FR 40410, Sept. lyzer.
14, 1982, as amended at 52 FR 17735, May 11,
1987; 66 FR 57368, Nov. 15, 2001) (a) Identification. An indwelling blood carbon dioxide partial pressure Pco2 8868.1400 Carbon dioxide gas anaanalyzer is a device that consists of a lyzer. catheter-tip Pco2 transducer (e.g., Pcoz (a) Identification. A carbon dioxide electrode) and that is used to measure, gas analyzer is a device intended to in vivo, the partial pressure of carbon measure the concentration of carbon dioxide in blood to aid in determining dioxide in a gas mixture to aid in dethe patient's circulatory, ventilatory, termining the patient's ventilatory, and metabolic status.
circulatory, and metabolic status. The (b) Classification. Class II (special device may use techniques such as controls). The special control for this chemical titration, absorption of infradevice is FDA'S “Class II Special Con- red radiation, gas chromatography, or trols Guidance Document: Indwelling mass spectrometry.